心脏瓣膜外科术后患者口服华法林抗凝治疗随访模式探讨

Exploration on follow-up pattern of oral warfarin anticoagulant therapy in patients after cardiac valve surgery

目的 探讨qLabs凝血检测仪联合远程抗凝管理平台在瓣膜外科术后患者口服华法林抗凝治疗随访管理中的应用效果及分析其可行性,为瓣膜外科手术后患者抗凝治疗随访管理寻求新模式。方法 选取东莞市人民医院2018年10月至2020年2月收治的心脏瓣膜病外科手术后口服华法林200例患者作为研究对象,按照随机原则(抽签法)将200例经治瓣膜外科手术后患者随访方式分成两组:qLabs凝血检测仪联合远程抗凝管理平台为新模式随访管理模式组(A组)和传统门诊随访管理模式组(B组),每组均100例。比较分析A、B两组口服华法林抗凝血治疗随访患者术后1、3、6个月及1年等时间点国际标准化比值(international normalized ratio,INR)达标率情况及华法林相关出血、血栓形成及栓塞、机械瓣膜功能障碍、死亡等不良事件的发生情况。结果 两组患者总体随访率A组为100%,B组为90%;A组并发症发生为2例,约2%;B组并发症发生为6例,约6.6%;A组总体随访率及并发症发生率明显低于B组,差异有统计学意义(P<0.05)。A组患者INR治疗窗达标率在1及3个月时间点均明显高于B组,差异有统计学意义(P<0.05);两组患者6个月及1年时间点INR治疗窗达标率比较,差异无统计学意义(P>0.05)。A组无死亡患者,B组病死率为2.2%;A组与B组患者出血(1%vs. 4.4%,P<0.05)、血栓(1%vs. 2.2%,P<0.05)、瓣膜功能障碍(1%vs. 2.2%,P<0.05)比较,差异有统计学意义。其中脑出血患者均发生在术后早期1个月内:A组1例患者合并感染性心内膜炎出现脑出血,INR值为2.2,属于抗凝强度适当,就诊及时成功获救;B组患者脑出血4例、消化道出血2例,INR值均高于5.8,均属于抗凝强度严重偏高,最终2例患者因大面积脑出血无法救治死亡。其中A组患者出现血栓及卡瓣为同一患者发生在术后11个月,合并心房颤动;其INR值为1.8,属于抗凝强度略偏低,监测频率为2周监测一次,急诊手术成功救治。B组2例患者(均伴有血栓及卡瓣),发生在手术后9个月,合并心房颤动;其INR值均低于1.35,属于抗凝强度严重偏低,监测频率为1个月监测一次,均急诊手术成功获救。结论 qLabs凝血检测仪联合远程抗凝管理平台能明显提高患者术后随诊率及INR治疗窗达标率,降低抗凝过度致脑出血风险及病死率,避免因抗凝强度不足出现血栓及卡瓣的风险;这种随访管理的应用效果明显,可作为一种新型抗凝随访管理模式。

Objectives To explore the application effect of qLabs coagulation detector combined with remote anticoagu⁃lation management platform in the follow-up management of oral warfarin anticoagulation treatment for patients after valvular surgery and analyze its feasibility,so as to seek a new model for the follow-up management of anticoagulation treatment for patients after valvular surgery.Methods A total of 200 patients with valvular heart disease admitted to Dongguan People′s Hospital from October 2018 to February 2020 were selected as subjects.In accordance with the principle of random method(draw),the 200 patients after valvular surgery with different follow-up management were divided into two groups:qLabs clotting detector joint remote anticoagulation management platform(a new model for follow-up management)group(A group)and conventional outpatient follow-up management model group(B group),100 cases in each group.International normalized ratio(INR)compliance rate at 1,3,6 months and 1 year after oral warfarin anticoagulant treatment,occurrence of adverse events such as warfarin-related bleeding,thrombosis and embolism,mechanical valve dysfunction and death were compared and analyzed between A group and B group.Results The overall follow-up rate was 100%in A group and 90%in B group.Complications occurred in 2 cases(about 2%)in A group and in 6 cases(about 6.6%)in B group.The overall follow-up rate and complication rate of A group were significantly lower than those of B group with statistically significant difference(P<0.05).The percentage of INR treatment window reached the standard in A group was significantly higher than that in B group at 1 and 3 months time point(P<0.05),and the difference was not statistically significant at 6 months and 1 year time point(P>0.05).There was no death in A group and mortality was 2.2%in B group.The differences of bleeding(1%vs.4.4%,P<0.05),thrombus(1%vs.2.2%,P<0.05)and valve dysfunction(1%vs.2.2%,P<0.05)between A group and B group were statistically significant.Among them,all cases of intracerebral hemorrhage occurred within 1 month in the early postop⁃erative period:1 patient in A group complicated with infective endocarditis presented intracerebral hemorrhage with an INR value of 2.2,indicating appropriate anticoagulant strength and timely rescue;In B group,there were 4 cases of intracerebral hemorrhage and 2 cases of gastrointestinal hemorrhage,both of which had INR values higher than 5.8,indicating that the anticoagulant intensity was seriously high;In the end,2 cases of intracerebral hemorrhage died due to large areas that could not be treated.Among the patients in A group,thrombosis and stuck valve occurred in the same patient 11 months after the operation,combined with atrial fibrillation.The INR value was 1.8,indicating slightly lower anticoagulant strength.The monitoring frequency was monitored once every 2 weeks,and emergency surgery was successful.In B group,2 patients(both accompanied by thrombus and stuck valve)occurred 9 months after surgery with atrial fibrillation.The INR values were all lower than 1.35,indicating that the anticoagulant strength was seriously low.The monitoring frequency was monitored once a month,and all the patients were rescued successfully in emergency surgery.Conclusions QLabs coagulation detector combined with remote anticoagulant management platform can signif⁃icantly improve the follow-up rate and INR treatment window standard rate,reduce the risk and mortality of cerebral hemorrhage caused by excessive anticoagulant,and avoid the risk of thrombus and flap due to insufficient anticoagulant intensity.This follow-up management can be used as a new anticoagulant follow-up management model.